HypernatremiaInCaNCT02912299
Investigation on Differences in Skin Sodium Content Between Normal Subjects and ICU-patients
An observational study of Hypernatremia, run by Frisius Medisch Centrum at 1 site in Netherlands.
Trial summary
This study investigates the differens in sodium storage in skin between normal subjects, patients after cardiac surgery and septic patients. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Hypernatremia
- What is being tested?
- Skin biopsies, Blood and urine analysis and Blood collection for RNA-investigation
- Type of treatment
- Surgery or procedure
- How many people
- 45 participants
- Where
- 1 siteNetherlands
- Study dates
- 3 Nov 2016to 5 Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * 15 patients admitted to the ICU with systemic inflammatory response syndrom in the presence of a(n expected) new infection * 15 patients admitted to the ICU after coronary artery bypass surgery, matched by gender and age (+/- 10 years) to the septic patients * 15 patients undergoing a hip replacement for arthrosis, matched by gender and age (+/- 10 years) to the septic patients
Who may be able to join
- 50-80 years (septic patients), 45-85 years (CABG and hip replacement-patients)
- Patients undergoing hip replacement: no relevant medical history (i.e. chronic and/or systemic diseases with a suspected influence on sodium / sodium handling)
- Septic patients: fulfilling the criteria for the systemic inflammatory response syndrome in the presence of a(n expected) new infection
Who cannot join
- Absence of both upper legs
- Skin disease that makes skin biopsies in healthy skin impossible
- Subjects with in their history formation of exaggerated scar tissue
- Subjects suffering from psoriasis or lichen ruber
- Use of skin corticosteroids on all skin of both upper legs < 2 weeks before inclusion
- Tattoos covering the whole surface of both upper legs
Show all 10Show fewer
- Use of diuretics in the past month
- Current renal replacement therapy
- Septic patients: not being sedated
- Patients undergoing hip replacement: hip replacement because of an inflammatory disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Onderzoek Naar Intracutane Natriumopslag Bij Intensive Care patiënten (InCa-studie)
This study investigates the differens in sodium storage in skin between normal subjects, patients after cardiac surgery and septic patients.
Read the detailed description
According to the current paradigm ICU-acquired hypernatremia is mainly an iatrogenic problem, caused by sodium overload or water deficit. In spite of several interventions to reduce sodium intake and optimize fluid balance, critically ill patients still develop hypernatremia. These patients also seem to have an inability to excrete sodium, hence develop a positive sodium balance. In animals sodium storage in the third compartment was found. Our hypothesis is that sodium storage in the third compartment is different in critically ill patients and this difference could play a role in the development of ICU-acquired hypernatremia.
- Conditions
- Hypernatremia
- Being tested
- Skin biopsies, Blood and urine analysis, Blood collection for RNA-investigation
- Medical subject headings
- Hypernatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin biopsiesProcedure or surgery
2 3mm skin biopsies will be taken
Blood and urine analysisOther
Measurement of sodium, potassium and kidneyfunction in blood and urine.
Blood collection for RNA-investigationOther
A blood sample that, in case of relevant differences between groups, could be used for RNA-profiling.
| Study group | Role | What they receive |
|---|---|---|
| Septic patients | Patients admitted to the ICU that fulfill the criteria for the systemic inflammatory response syndrome in the presence of a(n expected) new infection. 2 3mm skin biopsies will be taken, blood and urine analysis will take place and also blood collection for RNA-investigation. Receives: Procedure: Skin biopsies; Other: Blood and urine analysis; Other: Blood collection for RNA-investigation | |
| CABG patients | Patients admitted to the ICU after coronary artery bypass grafting. 2 3mm skin biopsies will be taken, blood and urine analysis will take place and also blood collection for RNA-investigation. Receives: Procedure: Skin biopsies; Other: Blood and urine analysis; Other: Blood collection for RNA-investigation | |
| Patients before hip replacement | Patients that will undergo a hip replacement because of arthrosis. 2 3mm skin biopsies will be taken, blood and urine analysis will take place and also blood collection for RNA-investigation. Receives: Procedure: Skin biopsies; Other: Blood and urine analysis; Other: Blood collection for RNA-investigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in sodium concentration in skin biopsy between groups
Skin biopsies will be taken within the described time frame, analysis will take place after all biopsies of all subjects are included
Measured: Different for the separate groups: before hip replacement, within 2 hours after CABG and within 12 hours after admission for septic patients
Secondary outcomes (8)
Immunohistochemistry: outcomes of proteoglycans
Measured: Different for the separate groups: before hip replacement, within 2 hours after CABG and within 12 hours after admission for septic patients
Immunohistochemistry: binding capacity of proteoglycans
Measured: Different for the separate groups: before hip replacement, within 2 hours after CABG and within 12 hours after admission for septic patients
Immunohistochemistry: density of lymph capillaries
Measured: Different for the separate groups: before hip replacement, within 2 hours after CABG and within 12 hours after admission for septic patients
Immunohistochemistry: presence of macrophage influx
Measured: Different for the separate groups: before hip replacement, within 2 hours after CABG and within 12 hours after admission for septic patients
Quantification of different matrix components / proteoglycans: decorine - if enough tissue is available
Measured: Different for the separate groups: before hip replacement, within 2 hours after CABG and within 12 hours after admission for septic patients
Quantification of different matrix components / proteoglycans: versican (if enough tissue is available)
Measured: Different for the separate groups: before hip replacement, within 2 hours after CABG and within 12 hours after admission for septic patients
Quantification of different matrix components / proteoglycans: biglycan- if enough tissue is available
Measured: Different for the separate groups: before hip replacement, within 2 hours after CABG and within 12 hours after admission for septic patients
mRNA profiling of proteoglycans and synthesizing enzymes by way of RNA-isolation - if enough tissue is available
Measured: Different for the separate groups: before hip replacement, within 2 hours after CABG and within 12 hours after admission for septic patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2016 (estimated)
- Study start3 Nov 2016
- Primary completion5 Sep 2017
- Study completion5 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HypernatremiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frisius Medisch Centrum
- Sponsor type
- University, hospital or other
- Collaborators
- University Medical Center Groningen
- Responsible party
- Sponsor
- Investigators
- Christiaan Boerma, MD PhD, Principal investigator, medical center leeuwardenJaap van den Born, PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02912299
- Sponsor's protocol ID
- NL 56729.099.16
- Acronym
- InCa
- Status last verified
- Sep 2017
- First submitted
- 13 Sep 2016
- Last updated
- 8 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Depending on the requests of the magazine involved.
Publications
Polderman KH, Schreuder WO, Strack van Schijndel RJ, Thijs LG. Hypernatremia in the intensive care unit: an indicator of quality of care? Crit Care Med. 1999 Jun;27(6):1105-8. doi: 10.1097/00003246-199906000-00029.
PubMed 10397213Waite MD, Fuhrman SA, Badawi O, Zuckerman IH, Franey CS. Intensive care unit-acquired hypernatremia is an independent predictor of increased mortality and length of stay. J Crit Care. 2013 Aug;28(4):405-12. doi: 10.1016/j.jcrc.2012.11.013. Epub 2013 Jan 29.
PubMed 23369520Lee JW. Fluid and electrolyte disturbances in critically ill patients. Electrolyte Blood Press. 2010 Dec;8(2):72-81. doi: 10.5049/EBP.2010.8.2.72. Epub 2010 Dec 31.
PubMed 21468200Titze J, Krause H, Hecht H, Dietsch P, Rittweger J, Lang R, Kirsch KA, Hilgers KF. Reduced osmotically inactive Na storage capacity and hypertension in the Dahl model. Am J Physiol Renal Physiol. 2002 Jul;283(1):F134-41. doi: 10.1152/ajprenal.00323.2001.
PubMed 12060595Titze J, Lang R, Ilies C, Schwind KH, Kirsch KA, Dietsch P, Luft FC, Hilgers KF. Osmotically inactive skin Na+ storage in rats. Am J Physiol Renal Physiol. 2003 Dec;285(6):F1108-17. doi: 10.1152/ajprenal.00200.2003. Epub 2003 Jul 29.
PubMed 12888617
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Onderzoek Naar Intracutane Natriumopslag Bij Intensive Care patiënten (InCa-studie)
- ClinicalTrials.gov ID
- NCT02912299
- Acronym / sponsor ID
- InCa / NL 56729.099.16
- Conditions
- Hypernatremia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Frisius Medisch CentrumUniversity, hospital or other
- Collaborators
- University Medical Center Groningen
- Study start
- 3 Nov 2016 (actual)
- Primary completion
- 5 Sep 2017 (actual)
- Study completion
- 5 Sep 2017 (actual)
- First posted
- 23 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates the differens in sodium storage in skin between normal subjects, patients after cardiac surgery and septic patients.
Detailed description
According to the current paradigm ICU-acquired hypernatremia is mainly an iatrogenic problem, caused by sodium overload or water deficit. In spite of several interventions to reduce sodium intake and optimize fluid balance, critically ill patients still develop hypernatremia. These patients also seem to have an inability to excrete sodium, hence develop a positive sodium balance. In animals sodium storage in the third compartment was found. Our hypothesis is that sodium storage in the third compartment is different in critically ill patients and this difference could play a role in the development of ICU-acquired hypernatremia.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Septic patients | – | Procedure: Skin biopsies, Other: Blood and urine analysis, Other: Blood collection for RNA-investigationPatients admitted to the ICU that fulfill the criteria for the systemic inflammatory response syndrome in the presence of a(n expected) new infection. 2 3mm skin biopsies will be taken, blood and urine analysis will take place and also blood collection for RNA-investigation. |
| CABG patients | – | Procedure: Skin biopsies, Other: Blood and urine analysis, Other: Blood collection for RNA-investigationPatients admitted to the ICU after coronary artery bypass grafting. 2 3mm skin biopsies will be taken, blood and urine analysis will take place and also blood collection for RNA-investigation. |
| Patients before hip replacement | – | Procedure: Skin biopsies, Other: Blood and urine analysis, Other: Blood collection for RNA-investigationPatients that will undergo a hip replacement because of arthrosis. 2 3mm skin biopsies will be taken, blood and urine analysis will take place and also blood collection for RNA-investigation. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * 15 patients admitted to the ICU with systemic inflammatory response syndrom in the presence of a(n expected) new infection * 15 patients admitted to the ICU after coronary artery bypass surgery, matched by gender and age (+/- 10 years) to the septic patients * 15 patients undergoing a hip replacement for arthrosis, matched by gender and age (+/- 10 years) to the septic patients
Key inclusion criteria (3 listed)
- 50-80 years (septic patients), 45-85 years (CABG and hip replacement-patients)
- Patients undergoing hip replacement: no relevant medical history (i.e. chronic and/or systemic diseases with a suspected influence on sodium / sodium handling)
- Septic patients: fulfilling the criteria for the systemic inflammatory response syndrome in the presence of a(n expected) new infection
Key exclusion criteria (10 listed)
- Absence of both upper legs
- Skin disease that makes skin biopsies in healthy skin impossible
- Subjects with in their history formation of exaggerated scar tissue
- Subjects suffering from psoriasis or lichen ruber
- Use of skin corticosteroids on all skin of both upper legs < 2 weeks before inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin biopsies2 3mm skin biopsies will be taken | Procedure or surgery | CABG patients, Patients before hip replacement, Septic patients |
| Blood and urine analysisMeasurement of sodium, potassium and kidneyfunction in blood and urine. | Other | CABG patients, Patients before hip replacement, Septic patients |
| Blood collection for RNA-investigationA blood sample that, in case of relevant differences between groups, could be used for RNA-profiling. | Other | CABG patients, Patients before hip replacement, Septic patients |
Primary outcome
Difference in sodium concentration in skin biopsy between groups
Time frame: Different for the separate groups: before hip replacement, within 2 hours after CABG and within 12 hours after admission for septic patients
Skin biopsies will be taken within the described time frame, analysis will take place after all biopsies of all subjects are included
8 secondary outcomes
Immunohistochemistry: outcomes of proteoglycans
Time frame: Different for the separate groups: before hip replacement, within 2 hours after CABG and within 12 hours after admission for septic patients
Immunohistochemistry: binding capacity of proteoglycans
Time frame: Different for the separate groups: before hip replacement, within 2 hours after CABG and within 12 hours after admission for septic patients
Immunohistochemistry: density of lymph capillaries
Time frame: Different for the separate groups: before hip replacement, within 2 hours after CABG and within 12 hours after admission for septic patients
Immunohistochemistry: presence of macrophage influx
Time frame: Different for the separate groups: before hip replacement, within 2 hours after CABG and within 12 hours after admission for septic patients
Quantification of different matrix components / proteoglycans: decorine - if enough tissue is available
Time frame: Different for the separate groups: before hip replacement, within 2 hours after CABG and within 12 hours after admission for septic patients
Quantification of different matrix components / proteoglycans: versican (if enough tissue is available)
Time frame: Different for the separate groups: before hip replacement, within 2 hours after CABG and within 12 hours after admission for septic patients
Quantification of different matrix components / proteoglycans: biglycan- if enough tissue is available
Time frame: Different for the separate groups: before hip replacement, within 2 hours after CABG and within 12 hours after admission for septic patients
mRNA profiling of proteoglycans and synthesizing enzymes by way of RNA-isolation - if enough tissue is available
Time frame: Different for the separate groups: before hip replacement, within 2 hours after CABG and within 12 hours after admission for septic patients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2017.
- Background: PubMed 10397213Polderman KH, Schreuder WO, Strack van Schijndel RJ, Thijs LG. Hypernatremia in the intensive care unit: an indicator of quality of care? Crit Care Med. 1999 Jun;27(6):1105-8. doi: 10.1097/00003246-199906000-00029.
- Background: PubMed 23369520Waite MD, Fuhrman SA, Badawi O, Zuckerman IH, Franey CS. Intensive care unit-acquired hypernatremia is an independent predictor of increased mortality and length of stay. J Crit Care. 2013 Aug;28(4):405-12. doi: 10.1016/j.jcrc.2012.11.013. Epub 2013 Jan 29.
- Background: PubMed 21468200Lee JW. Fluid and electrolyte disturbances in critically ill patients. Electrolyte Blood Press. 2010 Dec;8(2):72-81. doi: 10.5049/EBP.2010.8.2.72. Epub 2010 Dec 31.
- Background: PubMed 12060595Titze J, Krause H, Hecht H, Dietsch P, Rittweger J, Lang R, Kirsch KA, Hilgers KF. Reduced osmotically inactive Na storage capacity and hypertension in the Dahl model. Am J Physiol Renal Physiol. 2002 Jul;283(1):F134-41. doi: 10.1152/ajprenal.00323.2001.
- Background: PubMed 12888617Titze J, Lang R, Ilies C, Schwind KH, Kirsch KA, Dietsch P, Luft FC, Hilgers KF. Osmotically inactive skin Na+ storage in rats. Am J Physiol Renal Physiol. 2003 Dec;285(6):F1108-17. doi: 10.1152/ajprenal.00200.2003. Epub 2003 Jul 29.
- Individual participant dataSharing planned: Undecided. Depending on the requests of the magazine involved.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christiaan Boerma, MD PhD principal investigator
medical center leeuwarden
Jaap van den Born, PhD principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypernatremia, run by Frisius Medisch Centrum at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in sodium concentration in skin biopsy between groups (time frame: Different for the separate groups: before hip replacement, within 2 hours after CABG and within 12 hours after admission for septic patients). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02912299, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2017.